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Prolonged Adjuvant Temozolomide vs "Stop & Go" in Glioblastoma Patients

Study Purpose

This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay relapses in patients with glioblastoma compared to the standard care consisting in observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go arm).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with histologically confirmed diagnosis of GBM. 2. Availability of pre-treatment GBM tissue to determine the activation status of MGMT gene is not mandatory but strongly recommended. 3. Patients must have received radiation and TMZ for 6 weeks followed by 6 months of TMZ. Randomization should be performed within the 6 weeks after the last chemotherapy. 4. A brain MRI with or without a PET-Scan-methionine must be performed before enrolment. 5. Age ≥ 18 years. 6. Karnofsky Performance status ≥ 60. 7. Normal haematological functions: ANC ≥ 1.5 x 109cells/l, platelets ≥ 100 x 109 cells/l. 8. Normal liver function: total bilirubin < 1.5 x ULN, alkaline phosphatase and transaminases (ASAT/ALAT) < 2.5 times the upper limit of the normal range. 9. Serum creatinine < 1.5 x ULN. 10. Clinically normal cardiac function without history of ischemic heart disease in the past 12 months. Absence of cardiac insufficiency NYHA grade III and IV, instable angina, arrhythmia. 11. No previous or current malignancy (except treated basal or squamous cell skin carcinoma, cervix cancer or in situ carcinoma of the breast). 12. All patients (male and female) with reproductive potential must use effective contraception. Females must have a negative serum pregnancy test at entry to study. 13. Signed informed consent from the patient or legal representative must be obtained.

Exclusion Criteria:

All non inclusion criteria

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00643825
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jean-Francois Baurain, MD, PhD
Principal Investigator Affiliation	Cliniques universitaires Saint-Luc
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Unknown status
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Active Comparator: A: prolonged adj TMZ

Other: B : Stop and Go

Rechallenging patients with TMZ at relapse

Interventions

Drug: - Temozolomide

Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD

Drug: - Temozolomide

Observation till Progression then rechallenging with TMZ

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cliniques Universitaires Saint-Luc, Brussels, Europe, Belgium

Status

Recruiting

Address

Cliniques Universitaires Saint-Luc

Brussels, Europe, 1200

Site Contact

Jean-Francois BAURAIN, MD, PhD

jean-francois.baurain@@uclouvain.be

+32 2 764 54 71

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